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- Tasks: Lead analytical development strategy for biosimilar mAbs and ensure robust characterisation.
- Company: Growing biopharma organisation with a focus on innovative biosimilars.
- Benefits: Visa support for international applicants and opportunities for career advancement.
- Other info: High-visibility role with a dynamic team and global backing.
- Why this job: Make a real impact in the biosimilars field and shape the future of biopharma.
- Qualifications: Experience in biosimilars analytical development and strong technical expertise.
The predicted salary is between 60000 - 84000 £ per year.
BioTalent are partnered with a growing biopharma organisation strengthening its analytical development capability within a global biosimilars portfolio. This is not routine analytical testing. This is about building and defending a robust biosimilarity and analytical similarity strategy across monoclonal antibody programmes. The focus is deep molecule-level understanding, structural characterisation and regulatory-defensible data packages.
The Role
- Lead analytical development strategy for biosimilar mAbs, with responsibility across:
- Analytical similarity and biosimilarity assessment frameworks
- Comprehensive physiochemical characterisation of monoclonal antibodies
- Establishment and optimisation of HPLC methods including: Glycan profiling, CEX, SEC, Protein A, HIC
- Capillary electrophoresis techniques including cIEF and CESDS
- LCMS data interpretation for PTM identification and structural analysis
- Impurity profiling and degradation pathway assessment
- Method development, qualification and lifecycle management
- Statistical analysis and use of DoE in analytical method optimisation
- Support of Module 3 analytical content for IND, IMPD, BLA and MAA
- Interaction with Regulatory Affairs on EMA, MHRA and FDA queries
You will act as the analytical SME in cross-functional stage gate reviews, challenging interpretations and ensuring analytical conclusions are scientifically defensible. This role is technical leadership rather than daily wet-lab execution. You may not run assays yourself every day, but you will design the strategy, review the data and direct the technical path.
Essential Experience
- Direct biosimilars analytical development experience
- Demonstrated experience in analytical similarity and biosimilarity assessment
- Strong understanding of mAb structure, PTMs and higher-order structure
- Deep expertise across HPLC and CE platforms
- Ability to interpret LCMS data for structural differences
- Experience supporting regulatory submissions with analytical content
- Experience leading or mentoring analytical scientists
This is not suitable for:
- QC analysts focused on release testing
- Small molecule analytical chemists
- Scientists without biosimilars exposure
- Pure people managers lacking technical depth
Why Move
In biosimilars, analytical similarity is the battleground. This role owns how molecules are characterised, compared and defended. It is a high-visibility position within a growing technical site backed by global experience.
Analytical Development - Group Leader - Biosimilars/mAbs - UK Visa Support in Slough employer: BioTalent
Contact Detail:
BioTalent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Analytical Development - Group Leader - Biosimilars/mAbs - UK Visa Support in Slough
✨Tip Number 1
Network like a pro! Reach out to professionals in the biosimilars field on LinkedIn or at industry events. We can’t stress enough how important it is to make connections that could lead to job opportunities.
✨Tip Number 2
Prepare for interviews by brushing up on your technical knowledge and understanding of mAb structures. We recommend practising common interview questions related to analytical development to showcase your expertise.
✨Tip Number 3
Don’t just wait for job postings! Reach out directly to companies you’re interested in, like the one we’re partnered with. Express your enthusiasm for their work in biosimilars and see if they have any upcoming opportunities.
✨Tip Number 4
Utilise our website to apply for roles. It’s super easy and ensures your application gets seen by the right people. Plus, we’re here to support you every step of the way!
We think you need these skills to ace Analytical Development - Group Leader - Biosimilars/mAbs - UK Visa Support in Slough
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that match the job description. Highlight your direct biosimilars analytical development experience and any relevant projects you've led.
Craft a Compelling Cover Letter: Use your cover letter to tell us why you're passionate about biosimilars and how your expertise aligns with our needs. Be sure to mention your understanding of mAb structure and your experience with regulatory submissions.
Showcase Your Technical Skills: In your application, don't shy away from detailing your technical skills, especially in HPLC and CE platforms. We want to see how you can contribute to our analytical similarity and biosimilarity assessment frameworks.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity in our growing biopharma organisation.
How to prepare for a job interview at BioTalent
✨Know Your Molecules
Make sure you have a deep understanding of monoclonal antibodies and their structural characteristics. Brush up on biosimilarity assessment frameworks and be ready to discuss how you would approach analytical similarity in your previous roles.
✨Showcase Your Technical Skills
Be prepared to talk about your experience with HPLC methods, capillary electrophoresis techniques, and LCMS data interpretation. Highlight specific projects where you developed or optimised methods, and be ready to explain the impact of your work on regulatory submissions.
✨Prepare for Regulatory Discussions
Since this role involves interaction with Regulatory Affairs, it’s crucial to understand the requirements for IND, IMPD, BLA, and MAA submissions. Familiarise yourself with EMA, MHRA, and FDA guidelines, and think of examples where you’ve successfully navigated these processes.
✨Demonstrate Leadership and Mentorship
This position requires technical leadership, so be ready to discuss your experience in mentoring other scientists. Share examples of how you've led cross-functional teams or challenged interpretations during stage gate reviews to ensure scientifically defensible conclusions.